This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone both as a single administration and with a homologous prime-booster.
All vaccinations will be administered intramuscularly. In Groups 1-3, each volunteer will receive one vaccination in total. In Groups 4 and 5, each volunteer will receive two vaccinations in total. There are five different vaccine schedules: Group 1 (n=6) will receive 5 x 10\^9 vp ChAdOx1 MERS . Group 2 (n=9) will receive 2.5 x 10\^10 vp ChAdOx1 MERS. Group 3 (n=9) will receive 5 x 10\^10 vp ChAdOx1 MERS. Group 4 (n=6-12) will receive 2.5 x 10\^10 vp ChAdOx1 MERS at week 0 followed by a boost of 2.5 x 10\^10 vp ChAdOx1 MERS at week 26. Group 5 (n=6-12) will receive 2.5 x 10\^10 vp ChAdOx1 MERS at week 0 followed by a boost of 2.5 x 10\^10 vp ChAdOx1 MERS at week 4. The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples. Healthy adult volunteers will be recruited in Oxford, England.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
29
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, United Kingdom
Occurrence of solicited and unsolicited local and systemic adverse events
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration
Time frame: up to 28 days following vaccination
Measures of immunogenicity to the ChAdOx1 MERS vaccine
ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen
Time frame: 12 months
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